Blog Big Molecule Watch September 12, 2022

Biogen Files Sealed Complaint Against Sandoz and Polpharma Biologics Regarding Natalizumab

On September 9, 2022, Biogen filed a complaint in the District of Delaware against Sandoz and Polpharma Biologics.  Biogen’s complaint is filed under seal.  Based on the list of 28 asserted patents, the case appears to be a BPCIA litigation related to Sandoz and Polpharma’s proposed natalizumab biosimilar.  The asserted patents include patents directed to treating inflammatory and autoimmune diseases with natalizumab; methods of preventing and removing trisulfide bonds; methods for control of glycosylation in cell culture processes; and methods for depth filtration to clarify mammalian cell culture.  This appears to be Biogen’s first BPCIA suit asserting these patents against a biosimilar natalizumab developer.

This morning, Judge Connolly granted Biogen’s motion to file its complaint under seal, and ordered Biogen to file a redacted version of the complaint by September 19.

As we previously reported, Sandoz and Polpharma announced in July this year that the FDA and EMA had accepted its applications for its proposed natalizumab biosimilar to Biogen’s TYSABRI.  Under a global commercialization agreement entered into in 2019, Polpharma Biologics maintains responsibility for development, manufacturing and supply, and Sandoz has the rights to commercialize and distribute the product in all markets.

Stay tuned to Big Molecule Watch for further developments with this case.

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